Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: the locking mechanisms in claim 4-5, 8-9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Locking Mechanism of page 5 describes equivalents as projections…recess, etc.,
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim limitation “a member…in which it holds…in which the member…allow the lid portion to move to its open position” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification never mentions the equivalent of such “a member”. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. The limitation above is interpreted as ““the hinge…in which the hinge holds…in which the hinge…allow the lid portion to move to its open position”
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim 24 recites the limitation "the user graspable handle" in line 2. There is insufficient antecedent basis for this limitation in the claim. In effort to compact prosecution, the limitation is interpreted as –the projection—as stated in dependent claim 22.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 11-12, 14-15, 17-19, 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph (US 2014/0350500) in view of Zettle (US 2003/0052126).
Regarding claim 1, Joseph discloses ostomy collection device (10) including:
a housing (22) which defines a collecting volume for receiving and storing waste from an ostomy appliance (self-sealing stoma appliance, figure 1-3, [0031], [0037-0041]),
an inlet (42, figure 3) for fluidly connecting to an outlet (14) of an ostomy appliance so that waste from the ostomy appliance flows into the collecting volume ([0030-0036]),
an outlet (32) for emptying the contents of the collecting volume ([0041-0044]), but does not disclose a lid portion which is pivotable between a first position, in which the outlet is open and waste can flow through the outlet from the collecting volume, and a second position in which waste flow through the outlet is impeded or substantially prevented.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches a lid portion (100 having 300, figures 1-5) which is pivotable between a first position, in which the outlet is open and waste can flow through the outlet from the collecting volume ([0031], statement of waste can flow through the outlet from the collecting volume is a statement of intended use and Zettle is capable of performing this intended use), and a second position in which waste flow through the outlet is impeded or substantially prevented ([0026]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claim 2-3, Joseph discloses wherein the housing includes a top (24) and the inlet (42) is positioned on the top but does not disclose and the outlet positioned in or on the top.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches the outlet positioned on the top (figure 1-5), wherein the outlet (108) is located in a recess (104) formed in the top and the lid portion is receivable in the recess (figure 1).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. Further, it has been held that a rearrangement of parts by shifting the position of elements are unpatentable and considered a simple matter of design choice if the operation of the device would not have been modified (MPEP 2144). In this case, the rearrangement of the outlet from the bottom to the top of the device would not prevent the device from functioning normally since the material would also be removed from the top instead of the bottom.
Regarding claim 4, Joseph does not discloses further including a locking mechanism which inhibits and/or restricts movement of the lid portion out of its second position.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches a lid portion (300, figures 1-5) with a locking mechanism (314/316) which inhibits and/or restricts movement of the lid portion out of its second position ([0026]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claim 5, Joseph does not disclose wherein the locking mechanism includes a first formation and a corresponding formation which are engageable with each other to restrict and/or inhibit the lid portion moving out of its second condition.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches wherein the locking mechanism includes a first formation (314/316) and a corresponding formation (114 or edge of wall 102) which are engageable with each other to restrict and/or inhibit the lid portion moving out of its second condition ([0026]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claims 6-7, Joseph does not discloses wherein the first formation or corresponding formation includes a projection which extends outwardly from a surface and the other of the first formation and the corresponding formation includes a slot or recess wherein the first formation is located on the lid portion and the corresponding formation is on or in the housing.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches wherein the first formation or corresponding formation includes a projection (316) which extends outwardly from a surface and the other of the first formation and the corresponding formation includes a slot or recess (114), wherein the first formation is located on the lid portion (figure 5) and the corresponding formation is on or in the housing (figure 5).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claims 8-9, Joseph does not discloses wherein the first formation or the corresponding formation is movable translationally in the other of the first formation and the corresponding formation between a locking position in which the lid portion is inhibited and/or prevented from rotating and a rotating position in which the first formation and the corresponding formation form a hinge (claim 8), wherein the locking mechanism further includes the hinge which is attached to the first formation and moves between the locking position in which it holds the lid portion closed and rotating position in which the member is operable to move away from the lid portion and allow the lid portion to move to its open position (claim 9).
Zettle teaches wherein the first formation or the corresponding formation is movable translationally in the other of the first formation and the corresponding formation between a locking position in which the lid portion is inhibited and/or prevented from rotating and a rotating position in which the first formation and the corresponding formation form a hinge ([0026-0027]) wherein the locking mechanism further includes the hinge which is attached to the first formation and moves between the locking position in which it holds the lid portion closed and rotating position in which the member is operable to move away from the lid portion and allow the lid portion to move to its open position ([0026-0027]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claim 11, Joseph discloses wherein the housing includes a base (36) and a wall (22) and the top is connectable to and disconnectable from the wall (36 and 22 separable from 24 via 46, figure 5).
Regarding claim 12, Joseph discloses wherein the top and the wall include respective engagement formations (46 [0087-0088]) which are engageable to seal the top to the wall.
Regarding claim 14, Joseph discloses wherein a seal is provide on one of the engagement formations on the wall or the top ([0085]).
Regarding claim 15, Joseph discloses wherein the housing further includes an air vent arrangement (26, figures 6-7, [0054]).
Regarding claim 17, Joseph discloses wherein the housing includes a top (24) and the inlet (42) is positioned on the top but does not disclose and the outlet positioned in or on the top and wherein the air vent arrangement includes an opening in the top.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches an the outlet positioned on the top (figure 1-5), wherein the outlet (108) is located in a recess (104) formed in the top and the lid portion is receivable in the recess (figure 1).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. Further, it has been held that a rearrangement of parts by shifting the position of elements are unpatentable and considered a simple matter of design choice if the operation of the device would not have been modified (MPEP 2144). In this case, the rearrangement of the outlet from the bottom to the top of the device and air vent from side to the top would not prevent the device from functioning normally since the material would also be removed and vented.
Regarding claim 18, Joseph does not disclose wherein when the lid portion is in the second position the outlet is closed.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches a lid portion (300, figures 1-5) is in second position the outlet is closed ([0026]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Regarding claim 19, Joseph discloses further including a user graspable handle, and optionally the user graspable handle is pivotable between a first position and a second position.
Regarding claim 19, Joseph does not disclose including a user graspable handle.
Zettle discloses a user graspable handle (312 of lid 100).
Zettle provides an L panel formed including panel 312 in order to allow the device to connect and allow the lid to be movable by user ([0026]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph.
Regarding claims 22, and 24-25 Joseph does not disclose wherein the lid portion includes a projection for aiding the user to move the lid portion (claim 22), wherein the projection is positioned between the inlet and the outlet (claim 24), wherein the inlet is located on the lid portion and when the lid portion is in its second position the inlet is in fluid communication with the outlet and the collecting volume (claim 25).
Joseph further teaches wherein the lid portion includes a projection (112) for aiding the user to move the lid portion ([0023]), wherein the projection is positioned between the inlet and the outlet (figure 1), wherein the inlet is located on the lid portion and when the lid portion is in its second position the inlet is in fluid communication with the outlet and the collecting volume ([0026-0027]).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph.
Regarding claim 23, Joseph does not disclose wherein the inlet is located on an opposing side of the top to the outlet.
Zettle discloses a device reasonably pertinent to problem posed by Applicant of using a lid that controls the movement of material and teaches a lid portion (300, figures 1-5) wherein the inlet is located on an opposing side of the top to the outlet (106 and 108 on opposite sides).
Zettle provides a hinged cover in order to selectively control the movement of material ([007]) through alternatively covering the openings. It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph by modifying the lid to include the cover of Zettle to selectively control movement of material through the opening and alternatively, the lid is a functionally equivalent means to control the movement as the membrane currently used in Joseph. The substitution of the cover of Joseph with the hinged cover of Zettle would still allow the normal operation of the combined prior art device.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph in view of Zettle further in view of Lee (US 10449081).
Regarding claim 13, Joseph and Zettle do not disclose wherein the engagement formations are corresponding helical threaded portions.
Lee discloses an ostomy apparatus and teaches engagement formations (6 and 7, figure 5A-5B) are corresponding helical threaded portions (col 5, lines 18-27).
Lee provides the helical threads as a means to join the lid with the container (col 5, lines 18-27). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify and substitute the engagement formations in Joseph with the helical threads of Lee to connect/manipulate the lid with respect to the container. Both the closure mechanism in the Joseph and Lee are functionally equivalent ways to connect/manipulate the opening and would not change the function of the prior art devices.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph in view of Zettle further in view of Hofstetter (US 4356012).
Regarding claim 16, Joseph and Zettle do not disclose wherein the air vent arrangement includes a membrane which is water phobic to prevent or inhibit waste exiting the collecting volume through the air vent arrangement.
Hofstetter discloses a collection bag relatively pertinent to problem posed by Applicant of collecting material from the body and teaches wherein the air vent arrangement includes a membrane (14, figure 1) which is water phobic to prevent or inhibit waste exiting the collecting volume through the air vent arrangement (col 2, lines 10-17).
Hofstetter provides the hydrophobic filter to permit air to exit but not the liquid from the bag which would contaminate the exterior (col 2, lines 10-17). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph with the filter of Hostetter to prevent contamination of the device and allow air flow but prevent liquid flow.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Joseph in view of Zettle further in view of Cimino (US 2015/0352256).
Regarding claims 20-21, Joseph and Zettle do not disclose the first handle position is a carrying position in which the handle is substantially upright and the second handle position is a stowed position in which the handle lies substantially flat or in line with the housing (claim 20), and wherein the housing includes a top and the inlet and the outlet are positioned in or on the top and wherein the top includes a recess for receiving the handle in the stowed position (claim 21).
Cimino discloses a container for holding material relatively pertinent to problem posed by Applicant of collecting material from the body and teaches a handle (128) the first handle position is a carrying position in which the handle is substantially upright (figure 1) and the second handle position is a stowed position in which the handle lies substantially flat or in line with the housing (figure 2, [0110-0111]), and wherein the housing includes a top (106) and the inlet and the outlet are positioned in or on the top (figure 1, multiple outlet/inlet 114, 116, 118) and wherein the top includes a recess (recess interior to 106) for receiving the handle in the stowed position (figure 2).
Cimino provides the handle to allow user to grasp and suspend the device and prevent interference with the ports ([110]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Joseph with the handle of Cimino in order to allow user to grasp and suspend the device and prevent interference with the ports.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The cited prior art fails to teach wherein the first formation or the corresponding formation includes a narrowed channel and a wider rotation opening. Joseph and Zettle while teaching narrowed channel fails to teach the wider rotation opening. It would not be obvious to a person of ordinary skill in the art to modify the formations of Joseph and Zettle with a wider rotation opening as it would destroy the intended operation the cited prior art device. For these reasons, claim 10 is allowable if rewritten to include all the subject matter of preceding claims 4 and 8 in independent form.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781